MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 05/09/2018

Event Type  Death  

Manufacturer Narrative

The pipeline devices have not been returned for evaluation; product analysis cannot be performed.The devices have not been returned; the reported events could not be confirmed.The causes of the events could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2019-01074 2029214-2019-01075.If information is provided in the future, a supplemental report will be issued.

Event Description

Zhang, y., zhang, y., guo, f., liang, f., yan, p., liang, s., <(>&<)> jiang, c.(2018).Treatment of small and tiny aneurysms before and after flow diversion era: a single center experience of 409 aneurysms.World neurosurgery, 116.Doi: 10.1016/j.Wneu.2018.04.213.Medtronic literature review found reports of patient complications after pipeline (ped) placement.The purpose of this article was to evaluate ped as the primary treatment modality for small and tiny aneurysms at anterior circulation.The authors reviewed the results of 55 patients.The article describes the following complications: - 1 patient had subarachnoid hemorrhage (sah) before admission, and diagnostic dsa revealed an arteriovenous malformation (avm) with a hemodynamic-related aneurysm.The patient underwent ped placement plus coiling of the aneurysm.The patient experienced brain hemorrhage and died 20 days after the ped procedure.Hemorrhage was diagnosed in a local hospital.Whether the hemorrhage was from the aneurysm or the avm was not clear.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9236196
• MDR Text Key: 163701828
• Report Number: 2029214-2019-01076
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death